Cervical cancer is a fatal disease if not detected and treated early. 99.7% of cervical cancer cases are etiologically associated with at least one of 15-18 oncogenic types of human papillomavirus (4-6). Over 85% of cervical cancer occurs in developing countries and other historically underserved low-resource populations where it is the leading cause of death from cancer among women (1). Most high-grade cervical cancer can be prevented if pre-cancerous lesions or early-stage cervical cancer becomes diagnosed and treated.
At present, pre-cancerous lesions or early-stage cervical cancer can be detected using inexpensive screening methods, such as visual inspection of the cervix using acetic acid (vinegar) or Lugol's solution (iodine), or by using a new and affordable HPV-DNA test (careHPV, Qiagen) that can detect 14 high-risk types of HPV. However, there is a lack of affordable therapies for pre-cancerous cervical dysplasia. The costly and invasive therapies currently in use (cryotherapy, cone biopsies and loop electrosurgical excision procedure) all require both an established clinical infrastructure as well as highly trained medical personnel typically in the form of a dedicated gynecologic oncology service. Such resources are unavailable to large high-risk populations who have neither the economic means nor transportation options to access such clinical services. Thus, while limitations to screening in low resource settings appear to have been adequately addressed, there remains an unmet and urgent global need for an alternative therapy for those who have positive test results. The remaining challenge is to create a novel therapy for pre-cancerous cervical dysplastic lesions caused by high-risk types of HPV and prevent their progression to carcinoma in situ and/or invasive cervical cancer. Such a therapy should be inexpensive, easily self-administered or readily applied with assistance by a trained healthcare worker in a local clinic, and be effective as a single dose therapy that can be used in a single visit “screen, treat and prevent” public healthcare model that can be implemented even in the most impoverished populations where extremes of temperature may exist, space is limited and running water and electricity are unavailable.